製品名
Multilayer Durapore® 0.45/0.22 µm、オプティキャップ(Opticap)®XLカプセル, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 9/16 in. Hose BarbMax Operating Pressure: 80 psi @ 25 °C
Quality Segment
material
polyester support, polyethylene support, polypropylene filter, polypropylene housing, silicone outer O-ring, silicone-coated EPDM rubber lead O-ring
reg. compliance
FDA 21CFR177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
gamma compatible
product line
Opticap® XL 10
feature
hydrophilic
manufacturer/tradename
Opticap®
parameter
≤15.0 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water), 1 bar max. inlet pressure (15 psi) at 80 °C, 1.05 bar max. differential pressure (15 psid) at 80 °C (Forward:), 2.75 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward:), 5.5 bar max. inlet pressure (80 psi) at 23 °C, 80 psig max. inlet pressure
technique(s)
sterile filtration: suitable
W
4.2 in.
cartridge nominal length
10 in. (25 cm)
device L
33.5 cm (13.2 in.)
device size
10 in.
filter diam.
4.2 in. (10.7 cm)
filter filtration area
1.86 m2
inlet connection diam.
1-1/2 in.
inlet to outlet width
33.5 cm (13.2 in.)
outlet connection diam.
9/16 in.
impurities
≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <0.25 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Multilayer Durapore®
pore size
0.45/0.22 μm pore size
bubble point
≥3450 mbar (50 psig), air with water at 23 °C
fitting
1/4 in. fitting (vent/drain hose barb with double O-ring seal), (38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)
General description
Packaging
Preparation Note
Gamma compatible to 45 kGy; 3 autoclave cycles of 60min at 3°C; not in-line steam sterilizable
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
Analysis Note
Other Notes
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer Wetting Instructions for Filter Units with Durapore® Membrane user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
Legal Information
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